Dutasteride to Treat Women With Menstrually Related Mood Disorders

NCT00082043 | Completed Phase 1

• 2 other identifiers: 04013904-M-0139
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

This study will explore the effects of dutasteride on mood and the stress response across the menstrual cycle. Dutasteride blocks production of neurosteroids-hormones that help regulate the stress response systems. These systems may be disturbed in women with menstrually related mood disorders (MRMD). The effects of the drug will be compared in women with and without MRMD to determine how neurosteroids regulate mood and the stress response across the menstrual cycle. Dutasteride is approved by the Food and Drug Administration to treat benign prostatic hyperplasia (excess growth of the prostate gland) in men. Menstruating women 30 to 45 years of age with and without MRMD may be eligible for this study. Candidates are screened with a medical and psychiatric history, physical examination, screening for symptoms of depression, and routine blood and urine tests. Participants are required to use barrier contraception (condoms or diaphragm) during the 3-month study and 6-month follow-up. Participants undergo the following tests and procedures:

• Dutasteride or placebo treatment: Participants receive 1 month of dutasteride and 2 months of placebo. Neither the participants nor the investigators know when the subject is taking the active medication or the placebo.
• Biweekly follow-up visits: Every 2 weeks during the 3-month treatment period, patients come to the NIH Clinical Center to have blood drawn and to complete mood symptoms ratings.
• Monthly follow-up visits: Participants return to the Clinical Center once a month for 6 months after the end of the treatment period to monitor hormone levels and pregnancy status.

Conditions

Premenstrual Syndrome; PMS; Healthy; Depression

Keywords

Neurosteroids; 5 Alpha-Reductase Inhibitor; Depression; Menstrual Cycle; Gonadal Steroids; Menstrual Cycle Related Mood Disorder; MRMD; Healthy Volunteer

Outcome Measures

Primary Outcomes (1)

• Rating Scale for Premenstrual Tension (PMTS); Daily symptom rating form (DRF); Visual Analogue Symptom (VAS) self-rating form.

  Every 2 weeks for the PMTS; daily for the others.

Secondary Outcomes (1)

• Neuroendocrine response to DEX/crh test; Beck Depression Inventory (BDI)

  DEX/crf 2x second mth of tx, 1x during luteal ph & 1x during follicular ph.

Study Arms (2)

1

EXPERIMENTAL

Dutasteride 2.5 mg by mouth daily for one month

Drug: Dutasteride

2

PLACEBO COMPARATOR

Placebo oral capsule for two months

Drug: Placebo oral capsule

Interventions

Dutasteride DRUG

1

Placebo oral capsule DRUG

2

Eligibility Criteria

• Age: 30 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy controls and women who meet the criteria for MRMD.
• The criteria for MRMD, from Protocol 81-M-126, "The Phenomenology and Biophysiology of Menstrually Regulated Mood and Behavior Disorders," briefly are as follows:
• History within the last two years of at least six months with menstrually-related mood or behavioral disturbances of a severity sufficient to cause at least moderate subjective distress;
• Symptoms should have a sudden onset and offset, with symptoms most severe during the week prior to menstruation and tending to disappear abruptly on or about the first day menstruation;
• Age 30-50 years;
• In good physical health;
• Healthy controls will have no symptoms of MRMD (confirmed prospectively), be between the ages of 30 and 50, and be in good physical health.
• In addition all subjects will have a normal clinical breast exam prior to study entry.

You may not qualify if:

• Subjects will be excluded from the study for the following reasons:
• Pregnancy or any intent to become pregnant;
• Medical illness, in particular diabetes, cardiac or renal disease;
• Use of psychotropic or hormonal medications within three months prior to the study;
• Current prescription medication use;
• History of or current alcohol or drug abuse or dependence;
• A history of (within the past two years) or current psychiatric disorder determined by administration of the Structured Clinical Interview for DSM-IV Axis I Disorders (SCID);
• Male gender;
• Age less than 30 years; and
• Women with a history of carcinoma of the breast, or women with a family history of the following: premenopausal breast cancer or bilateral breast cancer in a first degree relative; multiple family members (greater than three relatives) with a history of postmenopausal breast cancer.
• In addition to the above, due to the long half life of dutasteride and its teratogenic effects on male fetuses, only women who have already decided to discontinue child-bearing and are willing to continue barrier contraception for 6 months after the study will be included in the protocol.

Sponsors & Collaborators

• National Institute of Mental Health (NIMH): lead

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

• Halbreich U, Borenstein J, Pearlstein T, Kahn LS. The prevalence, impairment, impact, and burden of premenstrual dysphoric disorder (PMS/PMDD). Psychoneuroendocrinology. 2003 Aug;28 Suppl 3:1-23. doi: 10.1016/s0306-4530(03)00098-2.

  PMID: 12892987 BACKGROUND

• Wittchen H -U, Becker E, Lieb R, Krause P. Prevalence, incidence and stability of premenstrual dysphoric disorder in the community. Psychol Med. 2002 Jan;32(1):119-32. doi: 10.1017/s0033291701004925.

  PMID: 11883723 BACKGROUND

• Rubinow DR, Roy-Byrne P. Premenstrual syndromes: overview from a methodologic perspective. Am J Psychiatry. 1984 Feb;141(2):163-72. doi: 10.1176/ajp.141.2.163.

  PMID: 6362441 BACKGROUND

MeSH Terms

Conditions

Premenstrual Syndrome; Depression

Interventions

Dutasteride

Condition Hierarchy (Ancestors)

Menstruation Disturbances; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Azasteroids; Steroids, Heterocyclic; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Pedro E Martinez, M.D.

  National Institute of Mental Health (NIMH)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 28, 2004
• First Posted: April 28, 2004
• Study Start: March 31, 2004
• Primary Completion: March 6, 2014
• Study Completion: March 6, 2014
• Last Updated: December 17, 2019

Record last verified: 2016-02-05

Locations

US (1)